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Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.

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ClinicalTrials.gov Identifier: NCT03123627
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

Brief Summary:

Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction thymoglobulin when developing CMV-specific cellular immunity after transplantation.

Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 + CMV after transplantation.

Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV) received induction with thymoglobulin

Patients meeting inclusion criteria will be randomized to:

  • Control Arm: valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS (Transplantation 2013:96:333-360).
  • Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the patient developed CMV-specific cellular immunity. Patients who did not develop CMV specific immunity continue prophylaxis until day +90.

Analysis: The incidence of CMV disease according to the strategy used was calculated using Kaplan-Meier curves that were compared using the log-rank test.


Condition or disease Intervention/treatment Phase
Kidney Transplant Infection Drug: New profilaxis Drug: Profilaxis recommended Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.
Actual Study Start Date : August 23, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: New profilaxis
Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
Drug: New profilaxis
Primary endpoint: incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation for use in clinical trials (Humar A. Am J Transplant 2006; 6:262-74) criteria.

Active Comparator: Profilaxis recommended by TTS
Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.
Drug: Profilaxis recommended
Secondary end points: percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMV-specific is defined as production of γ> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent).




Primary Outcome Measures :
  1. Incidence of CMV disease at 12 months after transplantation [ Time Frame: 12 months ]
    Incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation criteria for use in clinical trials



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant CMV-Seropositive
  • CD8+ Tcell CMV especific pretransplant (CMV-reactive quantiferon pretrasplant)
  • > 18 years (adult)
  • Receiving Thymoglobulin induction therapy
  • Receiving Valganciclovir prophylaxis

Exclusion Criteria:

  • Multivisceral transplants including kidney-pancreas.
  • HIV-infected Patients
  • Patients who can not comply with the monitoring protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123627


Contacts
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Contact: Juan Manuel Escandell Morales 0034677906567 juanmanuel.escandell@imibic.org
Contact: Aurora Paez Vega 625591566 aumapave@hotmail.com

Locations
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Spain
Hosìtal Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Juan Manuel Escandell Morales    0034677906567    juanmanuel.escandell@imibic.org   
Contact: Aurora Paez Vega    0034625591566    aumapave@hotmail.com   
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba

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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT03123627     History of Changes
Other Study ID Numbers: TIMOVAL
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Keywords provided by Maimónides Biomedical Research Institute of Córdoba:
Cytomegalovirus, Seropositive

Additional relevant MeSH terms:
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Valganciclovir
Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents